Download OviTex™ 1S Reinforced BioScaffold

OviTex™ 1S Reinforced BioScaffold
Resorbable Polymer
INSTRUCTIONS FOR USE
DESCRIPTION
OviTex™ 1S Reinforced BioScaffold with Resorbable Polymer (OviTex 1S)
is a sterile bioscaffold composed of ovine (sheep) derived extracellular
matrix (ECM) and polyglycolic acid (PGA). The device consists of two
sides: a textured and smooth side. The textured side of the device
provides a surface conducive for tissue ingrowth. The smooth side of the
device provides a surface designed to minimize tissue attachment.
OviTex 1S will incorporate into the recipient tissue with associated
cellular and microvascular ingrowth.
Textured side
Smooth side
OviTex 1S is provided in various shapes and sizes to suit surgeon
preference and the complexity of the soft tissue repair. The device may
be trimmed to a desired shape to further accommodate an individual
patient’s requirements.
INDICATIONS FOR USE
OviTex 1S is intended for use as a surgical mesh to reinforce and/or
repair soft tissue where weakness exists. Indications for use include the
repair of hernias and/or abdominal wall defects that require the use of
reinforcing or bridging material to obtain the desired surgical outcome.
CONTRAINDICATIONS
Do not use OviTex 1S in patients with a known sensitivity to materials of
ovine (sheep) origin. Use of OviTex 1S in this patient population may
result in an allergic or immunological reaction.
WARNINGS

Device is supplied sterile. Inspect the packaging to ensure it is intact
and undamaged prior to use.

Single use only. Reuse, resterilization, reprocessing and/or
repackaging may compromise the structural integrity and/or
essential material and design characteristics that are critical to the
overall performance of the device, which may result in device
failure and/or patient injury. Open and unused material should be
discarded.
PRECAUTIONS

Do not use the product past its expiration date. The expiration date
is displayed on the product labeling as the year (4 digits), month (2
digits), and day (2 digits) next to an hourglass symbol.

Place the device in maximum contact with healthy, wellvascularized tissue to promote cell ingrowth and tissue remodeling.
ADVERSE EVENTS
The following adverse events have been reported for surgical repair of
hernias (with or without a surgical mesh): pain, infection, hernia
recurrence, adhesion, bowel obstruction, bleeding, fistula, seroma,
perforation, mesh migration, and mesh contraction.
HOW SUPPLIED
OviTex 1S is packaged in a Tyvek/film double pouch configuration.
STORAGE
OviTex 1S should be stored in a clean, dry location at room temperature
(25 oC/77 oF).
CAUTION
Federal law restricts this device to sale by or on the order of a physician.
INSTRUCTIONS
These recommendations are designed to serve only as a general
guideline. They are not intended to supersede institutional protocols or
professional clinical judgment concerning patient care.
1.
2.
Inspect the packaging to ensure it is intact and undamaged.
Using aseptic technique, remove the inner pouch from its outer
pouch and place the inner pouch in the sterile field.
3. Open the inner pouch carefully and aseptically remove the device
using sterile forceps.
4. Place the device into a sterile dish in the sterile field.
5. Rehydrate the device in a sufficient volume of sterile saline or
sterile Lactated Ringer’s solution for a minimum of 5 minutes.
6. Prepare the site using standard surgical techniques.
7. Using aseptic technique, trim the device to fit the site, if necessary,
providing an allowance for overlap. Position the device to achieve
maximum contact between the device and surrounding tissue. To
facilitate cell migration and tissue ingrowth, an overlap of 3-5 cm
with healthy well-vascularized tissue is suggested.
Note: If the device is cut too small for the defect, excess tension may
be placed on the suture line. This can result in recurrence of the
original tissue defect or development of a defect in the adjacent
tissue.
8. Using aseptic technique, transfer the device to the surgical site and
suture, staple, or tack into place, avoiding excess tension.
Note: In circumstances where OviTex 1S may contact the viscera, it
is recommended to place the smooth side of the product in contact
with the viscera.
9. Complete the surgical procedure.
10. Discard any unused portions according to institutional guidelines
for medical waste.
Caution, see instructions for use

Do not reuse

Sterilized using ethylene oxide
Do not resterilize

25oC
Store in a dry location at room
temperature (25oC)
Keep dry
Rx only
Prescription use only
Manufacturer

Catalog number

Lot number

Expiration date
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Developed and manufactured by Aroa Biosurgery for
1 Great Valley Parkway, Suite 24
Malvern, PA 19355 USA
T (844) 835-2246
F (844) 455-8707
www.telabio.com
TELA BIO and OviTex are trademarks of TELA Bio, Inc.
Endoform is a registered trademark of Aroa Biosurgery, Ltd (formerly Mesynthes, Ltd)
© TELA Bio, Inc.
PI.9041.00, September 2015